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Quality standards Certified processes and precision component testing

ISO 9001 & EN ISO 13485 certifications – Our quality promise

1zu1 was one of the first companies in Austria to be certified by DEKRA according to ISO 9001. Last year's successful recertification guarantees our quality standard until November 15, 2027.

Since June 2025, we have also been certified according to EN ISO 13485. This internationally recognized standard specifies special requirements for a comprehensive quality management system for the development, manufacture, and supply of medical devices. It confirms that we adhere to the strictest quality standards and meet all applicable regulatory requirements in this highly sensitive area.

Our two certifications bring numerous advantages:

  • Transparent and efficient processes that are traceable and verifiable at all times
  • Identification and use of recommendations for improvement
  • Reduced error rates and costs
  • Increased product and process quality with a zero-error philosophy
  • Compliance with specific customer specifications and all applicable regulatory requirements

For us, quality standards have two dimensions: technology and processes. Only through the close connection between these two areas can reliable, sustainable, and efficient quality management be achieved.

Regular audits and continuous improvements ensure our high standards in the long term. They strengthen the trust of our customers and lay the foundation for the healthy growth and successful internationalization of our company.

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